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510(k) K832703

ARGON LASER SYS-MODEL 5000 by Cooper Medical Corp. — Product Code HQE

K832703 is an FDA 510(k) premarket notification submitted by Cooper Medical Corp. for the device "ARGON LASER SYS-MODEL 5000". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Cooper Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
August 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Cooper Medical Corp.

  • K840144 — YAG LASER 8000 GASTROINTESTINAL BLEE (May 18, 1984)
  • K833387 — ARGON LASER SURGICAL SYSTEM 770 (April 18, 1984)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)
  • K820261 — MONITOR CO2 LASER SYSTEM (March 5, 1982)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources